UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056840 |
|---|---|
| Receipt number | R000064956 |
| Scientific Title | Effect of physical properties on ease of swallowing of jelly-like nutritional foods. |
| Date of disclosure of the study information | 2025/01/27 |
| Last modified on | 2026/01/28 09:42:01 |
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Basic information
Public title
Effect of physical properties on ease of swallowing of jelly-like nutritional foods.
Acronym
Effect of physical properties on ease of swallowing of jelly-like nutritional foods.
Scientific Title
Effect of physical properties on ease of swallowing of jelly-like nutritional foods.
Scientific Title:Acronym
Effect of physical properties on ease of swallowing of jelly-like nutritional foods.
Region
| Japan |
Condition
Condition
Men and women over 75 years old
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluation of the ease of swallowing of jelly-like nutritional foods with different physical properties.
Basic objectives2
Others
Basic objectives -Others
The sound data obtained during swallowing of jelly-like nutritional foods with different physical properties is used for analysis. The differences between foods are evaluated based on the chewing time and swallowing time extracted from the swallowing sound and wave form.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Swallowing sound data when ingesting a jelly-like nutritional food that is chewed and swallowed.
Key secondary outcomes
Compare swallowing sound data with flavor evaluation and subjective evaluation.
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Jelly-like nutritional food.
Interventions/Control_2
Jelly-like nutritional food with different physical properties from intervention 1
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 75 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Men and women aged 75 years or older on the day consent was obtained for this study.
2) Those who have been fully informed of the purpose and content of this study, are capable of consenting, fully understand the content of the study, and have volunteered of their own volition and agreed to participate in the study in writing.
Key exclusion criteria
1) Persons with a history or current illness of the following:
Cerebrovascular disease
History of tumors related to swallowing
Diseases that affect swallowing function, including neurodegenerative and neuromuscular diseases
Respiratory disease
Upper digestive disease
Organic diseases of the larynx
2) Persons who have been diagnosed with a disorder related to eating and swallowing
3) Persons aged 70 or older who have been diagnosed with pneumonia
4) Persons with restrictions on food or fluid intake
5) Persons who have never eaten or do not like dry snacks (crackers, cookies, potato chips, rice crackers, etc.)
6) Persons with milk, wheat, or soybean allergies
7) Persons who require assistance when coming to the facility
8) Persons who have difficulty wearing the neckband
9) Persons who have difficulty understanding instructions
10) Other persons who the study manager, principal investigator, or representative investigator deems ineligible to be study subjects
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Yoshio |
| Middle name | |
| Last name | Toyama |
Organization
Meiji Co., Ltd.
Division name
R&D Division
Zip code
192-0919
Address
1-29-1 Nanakuni, Hachioji,Tokyo,192-0919,Japan
TEL
042-632-5824
yoshio.toyama@meiji.com
Public contact
Name of contact person
| 1st name | Tomoko |
| Middle name | |
| Last name | Hisajima |
Organization
Meiji Co., Ltd.
Division name
R&D Division
Zip code
192-0919
Address
1-29-1 Nanakuni, Hachioji,Tokyo,192-0919,Japan
TEL
042-632-5824
Homepage URL
tomoko.hisajima@meiji.com
Sponsor or person
Institute
Meiji Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Meiji Co., Ltd.
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
National Center for Geriatrics and Gerontology
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Meiji institutional Review Board
Address
1-29-1 Nanakuni, Hachioji ,Tokyo,192-0919,Japan
Tel
042-632-5900
MEIJI.IRB@meiji.com
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
PLIMES株式会社（茨城県）／PLIMES Co.,Ltd.(Ibaraki)
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 01 | Month | 27 | Day |
Related information
URL releasing protocol
https://www.sciencedirect.com/science/article/pii/S2534773X25000382
Publication of results
Unpublished
Result
URL related to results and publications
https://www.sciencedirect.com/science/article/pii/S2534773X25000382
Number of participants that the trial has enrolled
28
Results
Participants were healthy elderly people aged 75 years or older. Three types of foods, P, Q, and S, were consumed, and swallowing time was measured. Food P had a longer oral retention time than food Q (p=0.030). Food S had a longer oral retention time than food P (p=0.001). No significant differences were observed in swallowing time. The physical properties of semi-solid foods affect swallowing in the elderly. Individualizing food selection can promote safe intake.
Results date posted
| 2026 | Year | 01 | Month | 28 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Healthy elderly people aged 75 or over
Participant flow
Twenty-one participants were enrolled in Test 1, of which 14 were included in the analysis (mean age 81.6 years). Twenty-eight participants were enrolled in Test 2, of which 16 were included in the analysis (mean age 78.6 years). Participants were randomly assigned to meal order groups (e.g., P>Q or Q>P, or P>S or S>P). Allocation was performed using block randomization (block size 4), and the distribution of the first test food was adjusted to ensure equal distribution between men and women, taking into account the session schedule and participant gender. The allocation list was only accessible to the allocation administrator, and the order was communicated to the person handing out the test foods to participants. The staff handing out the foods were unaware of the overall allocation list. In this way, participant flow was managed and the study was conducted.
Adverse events
Not observed
Outcome measures
Primary outcome measures: Oral Processing Time (OPT) and Swallowing Duration (SD), which were measured using a neck-worn electronic stethoscope (NewW-MDSA) and synchronized video.
Secondary outcome measures: Subjective assessment of ease of swallowing and food characteristics. Participants rated each food on a 5-point scale, including taste, aroma, spread in the mouth, and ease of collection.
Other assessments: Water swallowing test (drinking 30 mL of water) and cracker eating test (measuring the time it took to eat and swallow one cracker).
Through these assessments, the impact of food physical characteristics on the swallowing behavior of older adults was analyzed.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2024 | Year | 10 | Month | 16 | Day |
Date of IRB
| 2024 | Year | 10 | Month | 10 | Day |
Anticipated trial start date
| 2024 | Year | 11 | Month | 25 | Day |
Last follow-up date
| 2024 | Year | 12 | Month | 19 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 01 | Month | 27 | Day |
Last modified on
| 2026 | Year | 01 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064956
